Quality & Compliance System Senior Specialist overseeing Quality Management Systems in a global biopharmaceutical company. Ensuring GMP compliance and continuous improvement in quality processes.
About the role
- Senior Associate in Regulatory Affairs at Amgen facilitating CMC submission execution for product development. Collaborating with global teams on regulatory strategies and activities impacting products.
Responsibilities
- Contribute as a key member of the global regulatory CMC product team
- Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions
- Contribute to the organization and preparation of CMC investigational product amendments, post‑market supplements/variations, and new marketing applications
- Document and archive CMC submissions and related communications in the document management system
- Initiate and maintain CMC product timelines at the direction of product lead
- Interface with the regulatory operations team
- Train staff on select CMC procedures and systems
- Provide report status of activities and projects to teams and department
- Participate in cross-functional special project teams
Requirements
- Relevant Bachelor’s degree or equivalent is essential
- Experience in manufacture, process development, quality assurance, quality control, or analytical development
- Regulatory CMC specific knowledge and experience
- Developed project management and organizational skills
- Strong and effective oral and written communication skills
Benefits
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Job title
Job type
Experience level
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Not specified
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